United States District Court, D. Maryland, Southern Division
HOSPIRA, INC. Plaintiff,
SYLVIA MATHEWS BURWELL, ET AL. Defendants.
GEORGE JARROD HAZEL, District Judge.
This Memorandum and Order addresses Plaintiff Hospira, Inc.'s Motion for Temporary Restraining Order, ECF No. 2, and supporting memorandum, ECF No. 2-1. The Court held an emergency hearing on Plaintiff's motion today, during which the Court heard oral argument from the parties. See ECF No. 6. Additionally, during the hearing, the Court granted two unopposed motions to intervene filed by plaintiff-intervenor Sandoz, Inc. ("Sandoz") and defendantintervenor Myland Institutional LLC's ("Myland"). See ECF No. 10. Both Sandoz and Myland were given an opportunity to present argument regarding Plaintiff's pending motion. For the reasons stated below, Plaintiff's Motion for Temporary Restraining Order is GRANTED.
Plaintiff Hospira ("Plaintiff") is the New Drug Application ("NDA") holder for dexmedetomidine hydrochloride, which it markets under the brand name Precedex. This action arises out of Defendant Food and Drug Administration's ("FDA") decision on August 18, 2014 that will effectively allow generic versions of Precedex to reach the market. See ECF No. 2-3. Within hours of FDA's decision, Plaintiff filed a complaint and motion for a temporary restraining order ("TRO") seeking to stay FDA's decision, as well as rescind any generic-drug approval action which FDA has taken predicated upon that decision. See ECF Nos. 1, 2.
Previously, Plaintiff had obtained approval from FDA for two FDA approved uses for Precedex. ECF No. 2-1 at 4. These approved uses, known as "indications" include (1) "sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting, [administered] by continuous infusion not to exceed 24 hours, " and (2) "sedation of nonintubated patients prior to and/or during surgical and other procedures." Id. at 4-5. Plaintiff owns U.S. Patent No. 6, 716, 867 ("the 867 Patent"). The 867 Patent gives Plaintiff exclusive rights over the claimed "methods of use" of Precedex. Plaintiff recently revised its use code which now covers "intensive care unit sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures." Id. at 8.
Companies seeking to bring a generic version of a brand drug product to market may submit an Abbreviated New Drug Application ("ANDA"). Id. at 4. In order to do so, however, the Food, Drug & Cosmetic Act ("FDCA") requires that an ANDA file one of four certifications with respect to each patent listed in the Orange Book: (i) patent information has not been submitted; (ii) the patent has expired; (iii) the ANDA applicant will not seek final FDA approval before the date the patent expires; or (iv) the brand's patent is invalid, unenforceable, or will not be infringed by the ANDA applicant's product ("paragraph IV"). Id. at 5-6 (citing 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV)). For purposes of this motion, the Court is only presented with issues surrounding paragraph IV.
Typically, when an ANDA applicant submits a paragraph IV certification, it must give notice to the holder of the patent. Id. at 6. Following notice, the patent holder then has a 45-day period in which to bring an action for patent infringement. Id. If a patent infringement action is brought, it automatically stays final FDA approval of the ANDA application until the court rules that the patent is not infringed, or until 30 months have passed, whichever occurs first. Id. at 6 (citing 21 U.S.C. § 355(j)(5)(B)). In limited circumstances, however, an ANDA applicant can bypass the paragraph IV certification and notice requirements and seek immediate review and then approval for its generic drug. Id.
An ANDA applicant seeking to bypass paragraph IV must state in its application that it is not seeking approval for an approved indication (an FDA approved use for the drug) covered by the patented method of use, but, instead, is seeking approval only for an approved indication that is not covered by any unexpired method-of-use patent. Id. (citing 21 U.S.C. § 355(j)(2)(A)(viii)). This statement is commonly referred to as a "section viii statement." Id. FDA can approve an ANDA that relies on a section viii statement only when (a) FDA has approved more than one indication for the particular drug, and (b) at least one of those indications is not covered by any of the brand's patents. Id. (citing 21 C.F.R. § 314.94(a)(12)(iii)(A)). In such a situation, a generic applicant will propose labeling for the generic drug that "carves-out" from the brand drug's approved labeling the patented methods of use. Id. at 6-7 (citing 21 C.F.R. § 314.94(a)(8)(iv)).
FDA concluded in its August 18, 2014 letter decision that the ANDA sponsors for generic versions of Precedex could submit a section viii statement so long as its label carved out any express references to the protected uses. See ECF No. 2-3. Almost immediately, Plaintiff filed a complaint and motion for temporary restraining order in this Court seeking to stay the effect of FDA's decision. Plaintiff contends that, as a consequence of this decision, generic versions of Precedex will flood the market and that Plaintiff will be without a full and adequate remedy. According to Plaintiff, this harm will occur at the moment of generic product launch; the harm will be irreparable; and this irreparable harm can be avoided only by the Court's granting Plaintiff's request for temporary and/or preliminary injunctive relief. The Court therefore held a hearing this afternoon to address the concerns raised by Plaintiff's motion for temporary restraining order.
Plaintiff seeks a TRO, pursuant to Fed.R.Civ.P. 65(b), or a preliminary injunction, pursuant to Fed.R.Civ.P. 65(a), to "stay the decision of the U.S. Food and Drug Administration ("FDA") in Docket No. FDA-2014-N-0087 (Aug. 18, 2014)... rescinding ab initio any generic-drug approval action which FDA has taken predicated upon that Decision, ordering FDA to recall any product sold or distributed under such an approval, and enjoining FDA from granting any further or additional approvals predicated upon the August 18 Decision in Docket No. FDA-2014-N-0087." ECF No. 2-1 at 1.
The grant of a TRO or preliminary injunction is an "extraordinary remedy that may only be awarded upon a clear showing that the plaintiff is entitled to such relief.'" Dewhurst v. Cnty. Aluminum Co., 649 F.3d 287, 290 (4th Cir. 2011) (quoting Winter v. Natural Resources Defense Council, 555 U.S. 7, 22 (2008)). The Fourth Circuit recognizes four requirements in conjunction with the Supreme Court's ruling in Winter v. Natural Resources that a party must show in order to be granted a TRO or a preliminary injunction:
(1) likelihood of success on the merits; (2) likelihood the movant will suffer irreparable harm in the absence of preliminary relief; (3) that the balance of equities tips in movant's favor; and (4) the injunction is in the public interest.
The Real Truth About Obama, Inc. v. Fed. Election Comm'n,
575 F.3d 342, 347 (4th Cir. 2009) (citing Winter, 555 U.S. at 20); see also Dewhurst, 649 F.3d at 290 (reaffirming the four requirements set forth in The Real Truth About Obama ). According to both The Real Truth About Obama and Dewhurst, the Fourth Circuit has determined that all four requirements must be met in order for a TRO or a preliminary injunction to be granted. The burden placed upon Plaintiff to state a ...